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Randomised Trial Comparing Metal and Plastic Biliary Stents Stents for Palliating Malignant Jaundice

Sponsor
University of Cape Town (Other)
Overall Status
Unknown status
CT.gov ID
NCT00731419
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
26
Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background:

When considering any malignancy with limited life expectancy, palliation and quality of life are paramount. Owing to the limited centres offering ERCP and endoscopic palliation in the South African state sector, patients often travel vast distances and spend large amounts of time away from family and social support structures, severely impairing their quality of life. Stent occlusion with resultant readmission to an ERCP accredited centre obviously compounds this problem.

The hypothesis we propose to test is whether metal stents as a primary procedure result in better patency rates, are more cost effective and improve quality of life than plastic stents. We propose to do this by means of a randomised trial determining the best method of palliation for inoperable distal common bile duct malignancies in the South African context.

Primary end-point Assessing the cost of metal versus plastic stenting in inoperable malignant distal common bile duct strictures in patients with expected survival of 3 months or more as palliation of symptomatic obstructive jaundice. Cost to be assessed in terms of hardware, hospital stay and readmissions for stent occlusion(patency) and complications Secondary end-point Assessing quality of life using a validated scoring system(EORTC QLQ 30) in patients receiving a metal or plastic biliary stent as definitive means of palliation of malignant obstructive jaundice

Hypothesis to be tested Metal stents are superior to plastic stents in terms of patency, resulting in more cost effective palliation of inoperable malignant jaundice and better quality of life due to fewer stent occlusions/episodes of cholangitis.

Condition or Disease Intervention/Treatment Phase
  • Device: SEMS
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Distal Malignant Biliary Obstruction: A Prospective Randomised Trial Comparing Metal and Plastic Stents in Palliation of Symptomatic Jaundice
Study Start Date :
Jun 1, 2007
Anticipated Primary Completion Date :
May 1, 2009
Anticipated Study Completion Date :
Aug 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: SEMS

Self expanding metal stent compared to plastic stent. Both recognised forms of treatment for condition

Device: SEMS
Comparing plastic and metal stents
Other Names:
  • Boston Scientific
  • biliary self-expanding metal stent
  • olympus plastic stent

    		•
    Active Comparator: Plastic stent

    Device: SEMS
    Comparing plastic and metal stents
    Other Names:
  • Boston Scientific
  • biliary self-expanding metal stent
  • olympus plastic stent

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall cost comparison of metal versus plastic stent in patients with limited life expectancy [6 months]

    Secondary Outcome Measures

    1. Quality of life assessment [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Symptomatic jaundice secondary to malignant distal CBD stricture

    • Contra-indication to resection (advanced disease/advanced age/poor surgical risk)

    Exclusion Criteria:

    • Hilar/proximal CBD obstruction

    • ECOG performance status 3 or 4

    • Duodenal obstruction

    • Previous stent placement

    • Inability to comply with follow-up

    • Ascites and liver metastases

    • Not possible to stent endoscopically

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groote Schuur Hospital Cape Town Western Cape South Africa 7925

    Sponsors and Collaborators

    • University of Cape Town

    Investigators

    • Principal Investigator: John M Shaw, FCS, MMed, University of Cape Town

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00731419
    Other Study ID Numbers:
    • 144/2007
    First Posted:
    Aug 11, 2008
    Last Update Posted:
    Aug 11, 2008
    Last Verified:
    May 1, 2007
    Keywords provided by , ,
    biliary
    obstruction
    malignant
    stent
    palliation
    Additional relevant MeSH terms:
    Jaundice

    Study Results

    No Results Posted as of Aug 11, 2008